Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE

PRIMARY OBJECTIVES

  • To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
  • To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

  • To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
  • To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
  • To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
278

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • SPMSD Investigational Site 120
      • Arras, France
        • SPMSD Investigational Site 103
      • Asnieres, France
        • SPMSD Investigational Site 155
      • Bersee, France
        • SPMSD Investigational Site 125
      • Besancon, France
        • SPMSD Investigational Site 121
      • Besancon, France
        • SPMSD Investigational Site 141
      • Blois, France
        • SPMSD Investigational Site 124
      • Blois, France
        • SPMSD Investigational Site 161
      • Boulogne Billancourt, France
        • SPMSD Investigational Site 194
      • Brest, France
        • SPMSD Investigational Site 148
      • Caen, France
        • SPMSD Investigational Site 117
      • Caen, France
        • SPMSD Investigational Site 147
      • Chalons En Champagne, France
        • SPMSD Investigational Site 135
      • Champdeniers, France
        • SPMSD Investigational Site 163
      • Chigny Les Roses, France
        • SPMSD Investigational Site 145
      • Cholet, France
        • SPMSD Investigational Site 157
      • Clamart, France
        • SPMSD Investigational Site 101
      • Collombey Les Belles, France
        • SPMSD Investigational Site 160
      • Collombey Les Belles, France
        • SPMSD Investigational Site 162
      • DAX, France
        • SPMSD Investigational Site 139
      • Draguignan, France
        • SPMSD Investigational Site 193
      • Essey Les Nancy, France
        • SPMSD Investigational Site 106
      • Essey Les Nancy, France
        • SPMSD Investigational Site 123
      • Essey Les Nancy, France
        • SPMSD Investigational Site 164
      • Floirac, France
        • SPMSD Investigational Site 136
      • Frouard, France
        • SPMSD Investigational Site 114
      • Haguenau, France
        • SPMSD Investigational Site 150
      • Illkirch Graffenstaden, France
        • SPMSD Investigational Site 113
      • Le Havre, France
        • SPMSD Investigational Site 197
      • Le Havre, France
        • SPMSD Investigational Site 198
      • Lingolsheim, France
        • SPMSD Investigational Site 107
      • Louverne, France
        • SPMSD Investigational Site 115
      • Manduel, France
        • SPMSD Investigational Site 140
      • Maromme, France
        • SPMSD Investigational Site 116
      • Marseille, France
        • SPMSD Investigational Site 153
      • Montpellier, France
        • SPMSD Investigational Site 134
      • Nogent Sur Marne, France
        • SPMSD Investigational Site 129
      • Ostwald, France
        • SPMSD Investigational Site 133
      • Poitiers, France
        • SPMSD Investigational Site 128
      • Pont A Mousson, France
        • SPMSD Investigational Site 130
      • Quimper, France
        • SPMSD Investigational Site 151
      • Rouen, France
        • SPMSD Investigational Site 102
      • Rouen, France
        • SPMSD Investigational Site 110
      • Rouen, France
        • SPMSD Investigational Site 199
      • Saint Ouen, France
        • SPMSD Investigational Site 152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301

Exclusion Criteria:

  • Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
  • Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
  • Known or suspected immune dysfunction
  • Receipt of medications / vaccination that may interfere with study assessments
  • Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
  • Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • Any medical condition that might interfere with the evaluation of the study objectives
  • Febrile illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TETRAVAC-ACELLULAIRE
Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Time Frame: Pre-booster dose (Day 0)
Pre-booster dose (Day 0)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Time Frame: Pre-booster dose (Day 0)
Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)
Time Frame: Pre-booster dose (Day 0)
Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)
Time Frame: Pre-booster dose (Day 0)
Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)
Time Frame: Pre-booster dose (Day 0)
Pre-booster dose (Day 0)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Time Frame: 1 month post-booster dose
1 month post-booster dose
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Time Frame: 1 month post-booster dose
1 month post-booster dose
Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)
Time Frame: 1 month post-booster dose
1 month post-booster dose
Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)
Time Frame: 1 month post-booster dose
1 month post-booster dose
Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)
Time Frame: 1 month post-booster dose
1 month post-booster dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Geometric mean titer for diphtheria
Time Frame: Pre-booster (Day 0) and 1 month post-booster dose
Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for tetanus
Time Frame: Pre-booster (Day 0) and 1 month post-booster dose
Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 1
Time Frame: Pre-booster (Day 0) and 1 month post-booster dose
Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 2
Time Frame: Pre-booster (Day 0) and 1 month post-booster dose
Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 3
Time Frame: Pre-booster (Day 0) and 1 month post-booster dose
Pre-booster (Day 0) and 1 month post-booster dose
Solicited injection site and solicited systemic reactions
Time Frame: From Day 0 to Day 7 post vaccination
From Day 0 to Day 7 post vaccination
Unsolicited injection site reactions and unsolicited systemic adverse events
Time Frame: From Day 0 to Day 28 days post vaccination
From Day 0 to Day 28 days post vaccination
Serious adverse events
Time Frame: From signature of informed consent up to last study visit of the subject
From signature of informed consent up to last study visit of the subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RVX01C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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